Vertebroplasty Comparable With Placebo for Acute Vertebral Compression Fractures
A ≥1.5 reduction in pain levels on the visual analog scale was considered clinically significant.
Patients in both groups experienced significant improvements in pain levels at all time points compared with baseline, but no intergroup differences were reported at any time point of the 12-month study. Between-group mean VAS differences ranged from -0.43 (at the 1-day follow-up) to 0.45 (12 months), with a mean VAS difference of 0.13 (95% CI, -0.41 to 0.66; P =.48) between baseline and 1 year.
Secondary outcomes (quality of life and disability) were also comparable in patients receiving vertebroplasty or a sham procedure, even after adjusting for opioid intake.
Analgesic use was reduced in both groups at all assessment points, with no difference between the vertebroplasty and sham groups at any time point. Two adverse events (respiratory insufficiency and a vasovagal response) were reported by patients who received vertebroplasty.
Study limitations included lack of a conservative management control group, not accounting for patients' other medical treatments, and possible selection bias.